Moderate-to-severe Plaque PsoriasisPhase 1NCT03710681
A Safety Study of Multiple Subcutaneous (s.c.) Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis
A Phase 1 study testing SHR-1314 in people with Moderate-to-severe Plaque Psoriasis, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
This is a multiple dose escalating and open labeled clinical trial to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple subcutaneous (s.c.) injections of SHR-1314 in adults with moderate-to-severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate-to-severe Plaque Psoriasis
- What is being tested?
- SHR-1314
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesChina
- Study dates
- 2 Aug 2018to 30 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at age between 18 and 65 years old at screening.
- History of chronic plaque-type psoriasis for at least 6 months, with either documented medical history of psoriasis for at least 6 months or confirmation of the diagnosis by the Investigator at screening, if the subject was diagnosed by another physician.
- At the time of randomization, moderate to severe plaque psoriasis, defined by:
- PASI score of 12 or greater and
- PGA score of 3 or greater and
- BSA affected by plaque-type psoriasis of 10% or greater.
- A subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.
- Body Mass Index (BMI) of 18 to 35 kg/m2 (inclusive) at screening.
Who cannot join
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate psoriasis) at screening.
- Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization.
- Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior to randomization.
- History of inflammatory bowel disease or have other ongoing active autoimmune diseases.
- At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- History of depression and/or suicidal ideation or any suicidal behavior based on clinical assessment by the investigator.
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- Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
- Are currently enrolled in, or discontinued from a clinical trial involving an IP within the last 4 weeks or at least 5 half-lives of the last dosing prior to randomization, whichever is longer; or concurrently enrolled (at randomization) in any other trials.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test at screening or Day 0.
- Females of childbearing potential (defined as all females physiologically capable of becoming pregnant) and males who are unwilling or unable to use highly effective contraception during the study and 21 weeks after the last administration of IP (anticipated 5 half-lives).
- History of alcohol or illicit drug abuse within the year prior to screening.
- Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the Investigator.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Huanshan Hospital , Shanghai Fudan University
Shanghai, Shanghai Municipality, 100037
Jinhua Xu, M.D. Ph.D, +86-13818978539, xjhhsyy@163.com
Guoying Cao, M.D. Master, +86-13651900963, sherley_76@163.com
- Recruiting
Huanshan Hospital , Shanghai Fudan University
Shanghai, 100037
Jinhua Xu, M.D. Ph.D, +86-13818978539, xjhhsyy@163.com
Guoying Cao, M.D. Master, +86-13651900963, sherley_76@163.com
About this study
Official title: Safety, Tolerability and Pharmacokinetics Studies Following Multiple Subcutaneous Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis
This is a multiple dose escalating and open labeled clinical trial to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple subcutaneous (s.c.) injections of SHR-1314 in adults with moderate-to-severe plaque psoriasis.
The primary objective of this study is to investigate the safety and tolerability of multiple doses of subcutaneous SHR-1314 in subjects with moderate-to-severe plaque psoriasis. Secondary objectives are to determine the pharmacokinetics (PK) and immunogenicity profile of SHR-1314 in subjects with moderate-to-severe plaque psoriasis.
Read the detailed description
16 subjects with 2 dose groups will be enrolled in the study, all of whom received the SHR-1314 without placebo control. There are 8 subjects in each cohort. The dose will be started at 160mg and will be escalated by following dose escalating rules. The primary endpoint is the safety and tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.
- Conditions
- Moderate-to-severe Plaque Psoriasis
- Being tested
- SHR-1314
- Keywords
- SHR-1314 Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1314Biological
Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Multiple subcutaneous injections of SHR-1314 at 160mg every two weeks Receives: Biological: SHR-1314 |
| Cohort 2 | Experimental | Multiple subcutaneous injections of SHR-1314 at 240mg every two weeks Receives: Biological: SHR-1314 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment-Emergent Adverse Events [Safety and tolerability]
Incidence and severity of adverse events, change from baseline in vital signs and 12-lead electrocardiogram.
Measured: Baseline to 168 days after first dose administration
Incidence of development of Anti-drug Antibodies (ADAs) [Safety and Tolerability]
Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study.
Measured: Baseline to 168 days after first dose administration
Secondary outcomes (4)
Assessment of PK parameter
time to maximum concentration (tmax)
Measured: Baseline to 168 days after first dose administration
Assessment of PK parameter
maximum concentration (Cmax)
Measured: Baseline to 168 days after first dose administration
Assessment of PK parameter
area under curve (AUC0-14days)
Measured: Baseline to 168 days after first dose administration
Assessment of development of Anti-drug Antibodies (ADAs)
Incidence of development of Anti-drug Antibodies (ADAs)
Measured: Baseline to 168 days after first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start2 Aug 2018
- Primary completion21 Apr 2019 (estimated)
- Study completion30 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710681
- Sponsor's protocol ID
- SHR-1314-103
- Status last verified
- Oct 2018
- First submitted
- 6 Sep 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics Studies Following Multiple Subcutaneous Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03710681
- Acronym / sponsor ID
- SHR-1314-103
- Conditions
- Moderate-to-severe Plaque Psoriasis
- Keywords
- SHR-1314 Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 21 Apr 2019 (estimated)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multiple dose escalating and open labeled clinical trial to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple subcutaneous (s.c.) injections of SHR-1314 in adults with moderate-to-severe plaque psoriasis.
The primary objective of this study is to investigate the safety and tolerability of multiple doses of subcutaneous SHR-1314 in subjects with moderate-to-severe plaque psoriasis. Secondary objectives are to determine the pharmacokinetics (PK) and immunogenicity profile of SHR-1314 in subjects with moderate-to-severe plaque psoriasis.
Detailed description
16 subjects with 2 dose groups will be enrolled in the study, all of whom received the SHR-1314 without placebo control. There are 8 subjects in each cohort. The dose will be started at 160mg and will be escalated by following dose escalating rules. The primary endpoint is the safety and tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: SHR-1314Multiple subcutaneous injections of SHR-1314 at 160mg every two weeks |
| Cohort 2 | Experimental | Biological: SHR-1314Multiple subcutaneous injections of SHR-1314 at 240mg every two weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female at age between 18 and 65 years old at screening.
- History of chronic plaque-type psoriasis for at least 6 months, with either documented medical history of psoriasis for at least 6 months or confirmation of the diagnosis by the Investigator at screening, if the subject was diagnosed by another physician.
- At the time of randomization, moderate to severe plaque psoriasis, defined by:
- A subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.
- Body Mass Index (BMI) of 18 to 35 kg/m2 (inclusive) at screening.
Key exclusion criteria (12 listed)
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate psoriasis) at screening.
- Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization.
- Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior to randomization.
- History of inflammatory bowel disease or have other ongoing active autoimmune diseases.
- At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1314Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection. | Biological | Cohort 1, Cohort 2 |
Primary outcome
Incidence and severity of Treatment-Emergent Adverse Events [Safety and tolerability]
Time frame: Baseline to 168 days after first dose administration
Incidence and severity of adverse events, change from baseline in vital signs and 12-lead electrocardiogram.
Incidence of development of Anti-drug Antibodies (ADAs) [Safety and Tolerability]
Time frame: Baseline to 168 days after first dose administration
Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study.
4 secondary outcomes
Assessment of PK parameter
Time frame: Baseline to 168 days after first dose administration
Assessment of PK parameter
Time frame: Baseline to 168 days after first dose administration
Assessment of PK parameter
Time frame: Baseline to 168 days after first dose administration
Assessment of development of Anti-drug Antibodies (ADAs)
Time frame: Baseline to 168 days after first dose administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-1314 in people with Moderate-to-severe Plaque Psoriasis, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianwen Chen, M.D. Ph.D (+86-18036611985, chenjianwen@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Treatment-Emergent Adverse Events [Safety and tolerability] (time frame: Baseline to 168 days after first dose administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.